The following data is part of a premarket notification filed by Medi Nuclear Corp., Inc. with the FDA for Safe-t-shield Mouthpiece.
| Device ID | K865093 |
| 510k Number | K865093 |
| Device Name: | SAFE-T-SHIELD MOUTHPIECE |
| Classification | Mouthpiece, Breathing |
| Applicant | MEDI NUCLEAR CORP., INC. 4501 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Russell W King |
| Correspondent | Russell W King MEDI NUCLEAR CORP., INC. 4501 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Product Code | BYP |
| CFR Regulation Number | 868.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-30 |
| Decision Date | 1987-01-15 |